Intravascular suturing device for simultaneously placing 3-7 sutures with ideal spacing to close large openings in vessels including calfified

Abstract

Centerboard entering vessel opening spreads it to a slit. Needle pairs in slots across centerboard width are at about 2 mm intervals inside vessel. Pushing a wedge or bridge wire between pairs spreads needle noses about 1 mm on either side of free edge of slit. Suture loop ends are attached to each pair. An outboard has legs on either side of centerboard with a foot on each leg that stands on either side of slit outside vessel. Needle nose housings in each foot are directly opposite needle noses. Operator turning a screw pushes needle noses through vessel wall overcoming resistance in calcified vessels and housings hold needle noses by detents. Removing device from body brings suture ends outside with suture loops across slit in ideal 2×2 pattern. Alternative configurations provide means of joining and cutting suture ends, with preformed knots slid to opening or clamping ends together with a clip.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS[0001]This is a new invention by the inventor of vascular devices disclosed in U.S. Pat. No. 7,771,442, U.S. Pat. No. 7,959,644, and U.S. Pat. No. 7,713,215, that require relatively large percutaneous openings in arteries for device entry; the object of the present patent application being to percutaneously close large openings such as 9 F to 32 F in vascular vessels; including calcified, with an ideal curved line of sutures placed simultaneously without tying and placing knots individually.FEDERALLY SPONSORED RESEARCH[0002]Not ApplicableSEQUENCE LISTING OR PROGRAM[0003]Not ApplicableBACKGROUND OF THE INVENTION[0004]1. Field of the Invention[0005]The field generally relates to vascular closure devices that use plugs, mechanical pressure, or sutures to close percutaneous openings of size 3-10 F. Specifically, the present device provides a means for simultaneously placing an ideal pattern of sutures in a vascular vessel that may be calcified to c...

AI Technical Summary

Benefits of technology

The patent describes a device used for repairing damaged blood vessels. It consists of two boards, with a centerboard in between, made of high-strength metal or polymer. The centerboard is designed to stretch a slit in the vessel wall when advanced through a guidewire. The device also includes needle pairs with small arms that hold suture loops. The needle arms are bent to fit through the slit and are pushed out to the sides to create a secure repair. The device is attached to an outboard, which holds the needle pairs. The invention allows for a minimally invasive repair of damaged blood vessels.

Problems solved by technology

Thus manual pressure is still the gold standard for access site management but the disadvantage of time required to ambulation has led to the evolution of many alternatives.

The flat wire disc is larger than the opening but is somewhat porous so does not seal the opening to achieve hemostasis.

This device is handicapped by two properties inherent to the technology.

First, the anchor placed inside is occasionally obstructive, either at the puncture site or with embolization.

Obese patients are among the best candidates for these alternatives because direct pressure on the skin of an obese person may be transmitted laterally through fat layers and away from the opening, thus providing insufficient pressure at the vessel.

This device is not intended for use with large openings, there is relatively little experience with it and it is not in common use.

However open surgery has its own disadvantages and risks, so some exceptions are made to allow off-label use of a Prostar XL® device or two Perclose® devices to make a “purse-string” closure of the opening, pulling four points on the edge of the opening to the center and thus producing a closure that is not ideal, is technically difficult to perform, has some complications, and is usable only under certain conditions.

Thus “off-label” is a workable solution for highly skilled practitioners but not a satisfactory long-term general solution for routinely closing large openings.

Another problem of placing sutures in arteries is that they are frequently calcified making it difficult to push a suturing needle through the vessel wall even when the surgeon can manually access the artery.

1. Millions of procedures are performed each year that require percutaneous openings of 3-6 F. Manual pressure is commonly used for closing openings of 3 F and there are numerous devices for closing openings up to 6 F, generally by plugging the opening with substances that are foreign to the body and thus not desirable.

2. The Perclose® device is approved for placing one suture to close opening up to 8 F. The Prostar XL® device is approved for placing two sutures in a cross pattern for a purse string closure of openings up to 8-10 F. Open surgery places any number of sutures in the ideal pattern of 2×2 to close openings of 24 F or even larger, but has the disadvantage of more risk and greater trauma have devices for closing openings percutaneously.

This off label use of devices is technically difficult, does not prevent narrowing the vessel, is done only under restricted conditions, and has other complications, so cannot be long-term solutions for closing openings larger than 8-10 F.

7. Another problem with placing sutures is the skill and time required to tie the ends of each suture with a special knot, run them individually to vessel wall and cut each with a special tool.

8. Still another problem with placing sutures is that arteries and veins are frequently calcified making it difficult to push a suturing needle through the wall and the wall stretches in the direction of applied needle force.

The surgeon can't place a finger in front of the needle to prevent the stretching and has no other means of counteracting this tendency.

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